Oxbryta was developed as a treatment for anemia in patients with Sickle Cell Disease (SCD). The drug was intended to improve hemoglobin levels and reduce the effects of sickle-shaped red blood cells. However, in September 2024, Oxbryta was recalled from both U.S. and international markets following alarming findings from post-clinical trials.
During these trials, Oxbryta was linked to several serious health risks, including increased risk of vaso-occlusive crises (VOC), organ damage, and death.
If you took Oxbryta (Voxelotor) and experienced severe complications, you may qualify to file an Oxbryta lawsuit against the manufacturer Pfizer Inc. At Rueb Stoller Daniel, we’re here to fight for the justice you deserve. Contact us today for a free case review.
What Is Oxbryta?
Oxbryta, also called by the generic name Voxelotor, is a prescription medication designed to treat sickle cell disease. The drug was developed by Global Blood Therapeutics and approved by the FDA in 2019.
Pfizer purchased Global Blood Therapeutics in 2022. Adverse events and fatal outcomes prompted Pfizer to issue a voluntary Oxbryta recall on September 25, 2024.
Sickle Cell Disease
Sickle cell disease (SCD) is a hereditary blood disorder that causes blood cells to develop a sickle or crescent shape. These sickle cells become hard and sticky and can block blood flow.
Sickle cell disease (SCD) can lead to serious complications, including:
- Infection
- Acute Chest Syndrome: This is a life-threatening emergency where sick cells block blood flow to the lungs.
- Stroke: Sickle cell patients have an increased risk of blood clots and stroke.
- Organ failure
- Vaso-occlusive crises (VOCs): These painful episodes happen when sickle-shaped cells block blood flow in small blood vessels.
- Hemolytic anemia: This happens when the body lacks sufficient healthy red blood cells or hemoglobin to carry oxygen. It can cause fatigue, weakness, and shortness of breath.
Traditionally, sickle cell disease treatment has focused on managing symptoms through blood transfusions and pain medications. Oxbryta was developed by Global Blood Therapeutics (GBT) to treat the underlying cause: abnormal hemoglobin.
Hemoglobin is the protein in red blood cells responsible for transporting oxygen throughout the body. In patients with sickle cell, defective hemoglobin causes red blood cells to become misshaped.
Oxbryta was designed to increase hemoglobin’s ability to bind to oxygen and reduce the prevalence of sickle-shaped cells. The goal was to improve overall blood flow and lower the risk of complications.
Oxbryta Side Effects and Severe Complications
While the most common Oxbryta side effects include nausea, diarrhea, and headaches, some individuals have suffered several allergic reactions.
Serious injuries and health risks linked to Oxbryta led to a recall. Oxbryta lawsuits allege that Global Blood Therapeutics (GBT) and Pfizer failed to adequately warn sickle cell patients taking Oxbryta about safety concerns.
Vaso-Occlusive Crises (VOC)
Patients taking Oxbryta have reported a higher frequency of vaso-occlusive crises (VOCs), also called sickle cell crises. These happen when sickle cells block blood flow in small blood vessels. The blockage reduces oxygen delivery to tissues and organs, leading to severe pain and potential long-term damage.
Vaso-occlusive crises (VOC) most often cause abdominal pain, joint pain, and pain in the bones or lungs. These painful episodes can last from a few hours to several days. In addition to pain, recurrent VOCs can cause life-threatening complications.
These sickle cell crises can cause:
- Acute chest syndrome
- Stroke
- Organ failure, including kidney failure
- Pulmonary embolism
Serious Health Risks and Death
Oxbryta has been linked to severe complications and even death. Post-marketing clinical trials reported a higher number of deaths in patients who took Oxbryta compared to those in the placebo group.
Oxbryta may increase the risk of:
- Organ damage, including kidney failure and liver failure
- Heart attack and stroke
It is critical for any individuals who took Oxbryta and experienced adverse effects to document their medical history and symptoms carefully.
Who Qualifies to File an Oxbryta Lawsuit?
If you or a loved one have experienced severe health complications after using Oxbryta, you may be eligible to file a lawsuit. At Rueb Stoller Daniel, we are dedicated to helping individuals who have suffered harm due to dangerous or defective drugs. To qualify for an Oxbryta lawsuit, individuals must meet the following criteria:
- Usage Requirements: You must have taken Oxbryta for at least 30 days.
- Complications After Oxbryta Use:
- Increased Vaso-Occlusive Crises (VOC)
- Stroke
- Heart Attack
- Organ Failure (e.g., kidney or liver failure)
- Death
If you experienced complications or lost a family member, our team can help you pursue justice and compensation. Contact Rueb Stoller Daniel today for a free case evaluation and to discuss your legal options.
Damages in an Oxbryta Lawsuit
Damages in an Oxbryta lawsuit aim to address the physical, emotional, and financial harm caused by the sickle cell disease medication. At Rueb Stoller Daniel, we are committed to fighting for the maximum compensation in your case.
Medical Expenses
Compensation for medical bills is a key component of an Oxbryta lawsuit. This may include:
- Emergency Care: Many individuals who suffered severe reactions, such as strokes or heart attacks, required immediate and costly emergency medical attention.
- Hospital Stays: Hospitalization due to organ failure or other complications can lead to significant medical bills.
- Ongoing Treatments: Long-term care, such as dialysis for kidney failure or rehabilitation for stroke recovery, can impose a heavy financial burden.
- Prescription Medications: Patients may require additional medications to manage health conditions that developed after taking Oxbryta.
- Future Medical Costs: Compensation may also include future medical expenses for chronic conditions or permanent disability.
Lost Wages and Loss of Earning Capacity
Adverse effects from Oxbryta can prevent individuals from returning to work, either temporarily or permanently. Plaintiffs can recover compensation for lost wages during recovery or while seeking medical treatment.
If injuries lead to long-term disability, victims may seek damages for the income they would have earned. This includes calculations for promotions, raises, and career progression that may now be unattainable.
Pain and Suffering
Oxbryta complications, such as increased vaso-occlusive crises (VOCs), strokes, or organ failure, often cause significant physical pain and emotional distress. Compensation for pain and suffering aims to address these non-economic damages. This category may include:
- Physical Pain: Severe pain from increased vaso-occlusive crises (VOCs).
- Emotional Distress: Anxiety, depression, or post-traumatic stress disorder (PTSD) stemming from the injuries and their impact on daily life.
- Loss of Enjoyment of Life: Damages for individuals whose injuries prevent them from enjoying activities or hobbies they once valued.
Other Out-of-Pocket Costs
Patients and families often face additional expenses that can be recovered in a lawsuit, such as:
- Travel Costs: Expenses for traveling to and from medical appointments.
- Home Modifications: Costs associated with adapting a home to accommodate a disability, such as installing wheelchair ramps or medical equipment.
- Caregiving Services: Payments for in-home care from professional caregivers or family members who had to leave their jobs to provide support.
Loss of Consortium
Spouses of individuals harmed by Oxbryta may be entitled to compensation for loss of consortium. This covers the loss of companionship, affection, and intimacy due to the injuries or death of their loved one.
Wrongful Death Damages
In tragic cases where Oxbryta use results in death, families may pursue a wrongful death lawsuit. Compensation in these cases may include:
- Funeral and Burial Costs: Financial support for end-of-life arrangements.
- Loss of Financial Support: If the deceased contributed to the family’s income, damages may include compensation for the lost financial contributions.
- Loss of Companionship: Families may also seek damages for the loss of the emotional support, guidance, and companionship of their loved one.
Punitive Damages
In cases where the drug manufacturer is found to have been especially negligent or reckless, courts may award punitive damages in an Oxbryta lawsuit. The criteria for punitive damages varies between states. An Oxbryta lawyer can assess if your case may qualify for punitive damages.
Filing an Oxbryta lawsuit can provide much-needed financial relief to individuals and families burdened by the drug’s serious side effects. At Rueb Stoller Daniel, we understand the profound impact that Oxbryta-related complications can have on your life. If you or a loved one has been affected, contact us today for a free consultation.
How to File an Oxbryta Lawsuit
If you’ve experienced serious health complications or lost a loved one, you may be entitled to compensation through an Oxbryta lawsuit. Filing a lawsuit might seem overwhelming, especially when you’re dealing with the physical, emotional, and financial toll of injuries or loss. That’s where Rueb Stoller Daniel comes in. Our experienced attorneys are dedicated to guiding you every step of the way.
Gathering Evidence
One of the first steps in pursuing an Oxbryta lawsuit is gathering the evidence necessary to support your case. An Oxbryta lawyer will work closely with you to gather evidence. This may include:
- Medical Documentation: Medical records that show your Oxbryta use and the health complications you experienced.
- Communication: Correspondence with your healthcare providers or the pharmacy about the drug, including warnings (or lack thereof) you received.
- Reports of Side Effects: Reports of adverse events and complications to healthcare providers or agencies like the FDA can support your Oxbryta lawsuit.
- Expert Testimony: Medical experts play a key role in defective drug lawsuits. These experts can testify about the serious risks of Oxbryta.
The sooner you reach out, the better we can help preserve critical evidence and build a strong foundation for your Oxbryta lawsuit.
Settlement Negotiations or Trial
Most lawsuits, including those related to defective drugs, are resolved through settlements. At Rueb Stoller Daniel, our priority is to secure the best possible outcome for you, whether through negotiation or litigation.
Drug companies have skilled legal teams protecting their interests. Our experienced mass tort attorneys at Rueb Stoller Daniel aggressively advocate for clients.
If your Oxbryta lawsuit moves to court, Rueb Stoller Daniel will provide steadfast representation at every stage. Our trial attorneys are experienced in handling complex litigation.
FAQs
What Is the Statute of Limitations for Oxbryta Lawsuits?
The statute of limitations sets a deadline for filing an Oxbryta lawsuit. This time period can vary by state and often ranges from one to three years. Waiting too long to file your lawsuit may jeopardize your ability to seek compensation.
You should talk with a knowledgeable Oxbryta lawyer as soon as possible. They can help you understand the specific deadlines that apply to your case and ensure that all necessary paperwork is filed on time.
How Much Does an Oxbryta Lawyer Cost?
At Rueb Stoller Daniel, we operate on a contingency fee basis. This means there are no upfront costs and we only get paid if you win your case. Your Oxbryta lawyer receives a percentage of the settlement or lawsuit payout.
Oxbryta Recall Information and Timeline
Accelerated FDA Approval of Oxbryta
Oxbryta (Voxelotor) was developed to treat sickle cell disease (SCD), a genetic blood disorder characterized by abnormally shaped red blood cells leading to severe health complications. The U.S. Food and Drug Administration (FDA) granted Oxbryta accelerated approval in November 2019 for patients aged 12 and older, and expanded this approval in December 2021 to include children aged 4 to 11.
Accelerated approval for Oxbryta was based on its ability to increase hemoglobin levels, a marker indicating potential clinical benefit for sickle cell disease management.
Oxbryta Linked to Serious Health Complications
The FDA’s accelerated approval process allowed Oxbryta to reach the market quickly. However, postmarketing clinical trials raised safety concerns about dangerous complications.
Studies showed an increased rate of vaso-occlusive crises (VOCs) among patients taking the drug. VOCs are painful episodes caused by the obstruction of blood flow due to sickled red blood cells, leading to tissue ischemia and severe pain. Alarmingly, some studies also reported a higher rate of fatal events in patients treated with Oxbryta compared to those receiving a placebo.
In the HOPE Kids 2 trial involving 236 children, there were eight deaths among patients taking Oxbryta compared to two in the placebo group. There were 8 deaths among participants in the RESOLVE study, which examined sickle cell patients with leg ulcers.
Oxbryta Recall
The growing body of evidence led to a voluntary recall by Pfizer Inc.
- July 2024: The European Medicines Agency (EMA) initiated a review of Oxbryta following reports of increased mortality and VOCs in clinical trials.
- September 25, 2024: Pfizer announced a voluntary withdrawal of Oxbryta from all global markets. This decision was based on clinical data that the risks of Oxbryta, including increased VOCs and fatal events, outweighed its benefits.
- September 26, 2024: The FDA issued an alert about the Oxbryta recall, advising healthcare professionals to stop prescribing Oxbryta and encouraging patients to talk with their doctors about stopping Oxbryta and starting a different sickle cell disease treatment.
Why Choose Rueb Stoller Daniel?
At Rueb Stoller Daniel, we’re here to help you navigate the legal process and fight for the maximum compensation. We listen to your story and provide personalized attention to your case, treating you like a person, not just a file number.
Our attorneys have extensive experience in mass tort and product liability cases, making us highly qualified to handle your Oxbryta lawsuit. Gregory Rueb, Paul Stoller, and Stephen Daniel have over fifty years of combined experience and have represented tens of thousands of clients across the country. We have recovered hundreds of millions of dollars for clients.
Our mass tort and class action attorneys hold leadership positions in multiple Plaintiff Steering Committees. Our team has earned a variety of awards and memberships.
Contact an Oxbryta Lawyer Today
At Rueb Stoller Daniel, we understand the challenges patients with sickle cell disease face and the risks associated with Oxbryta. If you or a loved one has suffered due to Oxbryta, don’t wait to take action. Contact us today to schedule your free consultation.
You can reach us by calling 1-866-CALL-RSD or filling out our online form. We are available 24/7.
